America

October 16, 2019

US Food And Drug Administration Issues Warning Letter To Torrent Pharma, Blaming Its Management For Violations


[ By Bobby Anthony ]

Pharma

The United States Food & Drug Administration (FDA) has blamed Torrent Pharmaceuticals Ltd’s executive management of repeated violations across multiple plants in its warning letter to the company's Indrad plant in Gujarat.

In its warning letter, the US regulator has pointed out plant officials at both its Indrad and Dahej plants do not follow written procedures for drug manufacturing and their inability to thoroughly review unexplained discrepancy and failure of a batch of medicines.

It may be recalled that the US FDA had inspected Torrent Pharma’s facility in Dahej in March, after which it had issued certain observations which were later categorized as OAI.

The US regulator’s warning letter cited repeated failures at multiple sites, which it stated demonstrated that the executive management’s oversight and control over the manufacture of drugs is inadequate.

The regulator has directed the company to immediately and comprehensively assess its global manufacturing operations to ensure that manufacturing systems, processes, and products meet US FDA standards.

Incidentally, Torrent Pharma had informed stock exchanges that the US FDA had issued a warning letter to its Indrad plant after an inspection of the facility in April.

After the regulator inspected the Indrad facility in April, the US FDA had stated that the company had failed to thoroughly review any unexplained discrepancy and failure of a batch, and also failed to review written procedures.

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